System and method for all-inside suture fixation for implant attachment and soft tissue repair

ABSTRACT

A system for repairing a meniscus includes a suture including a first anchor, a second anchor, and a flexible portion connecting the first anchor and the second anchor. The flexible portion includes a self-locking slide knot between the first anchor and the second anchor. The system also includes a needle having a longitudinal extending bore and an open end. The bore is configured to receive the first anchor and the second anchor. The system further includes a pusher configured to be movable within the bore of the needle. The pusher is configured to (1) discharge the first anchor and the second anchor, and (2) push the self-locking slide knot after the discharge of the second anchor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority from U.S. ProvisionalPatent Application No. 60/650,131, filed Feb. 7, 2005 and entitled“SYSTEM AND METHOD FOR ALL-INSIDE SUTURE FIXATION FOR IMPLANT ATTACHMENTAND SOFT TISSUE REPAIR,” the entire content of which is incorporatedherein by reference.

BACKGROUND

1. Field of the Invention

The present invention relates generally to a system and method forattaching an implant during meniscal repair and for other soft tissuerepair. More particularly, the present invention relates to a system andmethod for an all-inside suture fixation device and method designed forthe placement of surgical anchors for the attachment of an implant tothe meniscus and for soft tissue repair. The present invention alsorelates to a system designed to reduce, or bring into closeapproximation, pieces of torn or damaged soft tissue to facilitatetissue repair and healing.

2. Description of Related Art

There are current procedures for surgical attachment of a soft tissueimplant in a joint, such as an autograft, allograft, or xenograft tissueor other compatible tissues and/or devices. Such implants may bebioresorbable and/or non-resorbable, synthetic and/or non-synthetic. Oneexample of a bioresorbable implant is the ReGen® CMI™, a collagen-basedmeniscus implant, the surgical attachment of which can involvetechniques that are difficult to master. There is a need, therefore, fora fixation device to facilitate a faster, easier to use method forattaching an implant to a host tissue. Suture fixation devices, such asthe FAST-FIX™ and RAPIDLOC™, which were designed to repair tears inmeniscus tissue, have certain limitations in their delivery of anchorsto attach an implant to the meniscal rim in that they may causeunnecessary destruction to the implant and require additionalinstruments and steps that are not integral to the device itself. Theneedle used to pass the anchor through an implant and through themeniscal rim punctures the implant in a manner that may lead to tearingof the implant matrix. There is a need, therefore, for a dimensionallysmaller device that employs a smaller needle that delivers a lessdestructive anchor through an implant and the meniscus, thereby reducingthe size of the puncture hole in the implant and the potential fortearing the implant matrix.

There is a need, therefore, for a fixation device that includes anintegrated knot pusher to secure the delivered anchor, and optionally,also includes a suture cutter for use after one or more anchors havebeen secured. Techniques that require separate instruments for knotpushing and suture cutting are less efficient, and require greaterskill, time, and additional manipulation at the surgical site.

Prior art devices and methods for suture fixation of an implant to softtissue within a joint typically tear the matrix of the implant duringneedle insertion and/or anchor delivery. There remains a need for adevice and method for fixing an implant to soft tissue that can insertanchors through the implant and host tissue with minimal destruction ofthe implant, in a well-controlled and easy manner. Also, there remains aneed for a device and method for fixing a collagen-based meniscusimplant to the host meniscal tissue, in a well-controlled and easymanner, whereby the needle and anchor insertion cause minimal to nodestruction of the collagen-based meniscus implant. Also, there remainsa need for a device and method for fixing a collagen-based meniscusimplant to the host meniscal tissue that puts adequate tension betweenthe anchors in a well-controlled and easy manner.

BRIEF SUMMARY OF THE INVENTION

The fixation delivery system of the present invention is an integrateddesign for use with the multiple elements required for suture fixationwhen attaching a soft tissue implant to host tissue or when performingtissue repair procedures in general. The present system and methodachieves the deployment of anchors into soft tissue and knot pushingwith the use of a single instrument, and, optionally, may also providefor suture cutting within that single instrument. The hollow needleapplicator and anchors are of smaller dimensions than currentapplicators and anchors to minimize the damage to the implant duringneedle insertion and anchor deployment.

In an embodiment of the invention, the applicator for deployment of theanchors includes a hollow needle or cannula having a longitudinalextending bore and an open end, into which a suture, which includes twosurgical anchors, is loaded. The first anchor and the second anchor areconnected via a flexible portion of the suture. The flexible portionincludes a self-locking slide knot located between the first anchor andthe second anchor. The needle is inserted into an incision already madein the patient's body, through the implant, and through the hostmeniscus to the outside rim of the meniscus, or through the soft tissuerequiring repair. Alternatively, the needle may penetrate directlythrough the patient's skin and into the joint capsule comprising theknee. The first anchor is ejected from the tip of the hollow needle bygripping the handle of the applicator and pulling the trigger, whichadvances a push rod within the hollow needle. The anchor is releasedfrom the open end of the needle to seat firmly on the surface of thesoft tissue or rim of the meniscus (i.e., the meniscus rim). The needleis removed from the initial insertion site and inserted through theimplant and through the meniscus or host soft tissue a short distancefrom the initial insertion point, without removing the needle from thepatient's body. The second anchor is deployed by gripping the trigger ofthe applicator to advance the push rod a second time and release thesecond anchor. The needle is withdrawn or retracted from the secondinsertion site, thereby leaving two anchors positioned on the outsiderim of the meniscus. The push rod, or pusher, functions as a knot pusherand can be used to push a self-locking slide knot, located on theflexible portion between the first and second anchors, until the knot isflush with the implant. Also, the flexible portion may be tightened byhand until adequate tension is applied to hold the pair of anchorsfirmly in place. Excess length of the flexible portion/suture can be cutusing a cutter, which may be in the form of a suture cutting surface onthe applicator. Again, the system is designed so that the deployment ofthe anchors, the pushing of the self-locking slide knot, and theoptional cutting may all be completed without removing the needle fromthe patient's body.

In an embodiment, a system for repairing a meniscus is provided. Thesystem includes a suture that includes a first anchor, a second anchor,and a flexible portion connecting the first anchor and the secondanchor. The flexible portion includes a self-locking slide knot betweenthe first anchor and the second anchor. The system also includes aneedle having a longitudinal extending bore and an open end. The bore isconfigured to receive the first anchor and the second anchor. The systemfurther includes a pusher configured to be movable within the bore ofthe needle. The pusher is configured to (1) discharge the first anchorand the second anchor, and (2) push the self-locking slide knot afterthe discharge of the second anchor.

In embodiment, a method for repairing a meniscus is provided. The methodincludes providing a system for repairing a meniscus. The systemincludes a suture that includes a first anchor, a second anchor, and aflexible portion connecting the first anchor and the second anchor. Theflexible portion includes a self-locking slide knot between the firstanchor and the second anchor. The system also includes a needle having alongitudinal extending bore and an open end. The bore is configured toreceive the first anchor and the second anchor. The system furtherincludes a pusher configured to be movable within the bore of theneedle. The pusher is configured to (1) discharge the first anchor andthe second anchor, and (2) push the self-locking slide knot after thedischarge of the second anchor. The method also includes providing animplant, passing the needle of the system through the implant and themeniscus at a first location to deliver the first anchor to an oppositeside of the meniscus, retracting the needle from the meniscus and theimplant, passing the needle of the system through the implant and themeniscus at a second location to deliver the second anchor to theopposite side of the meniscus, and pushing the self-locking slide knotto a surface of the implant.

In an embodiment, a method for repairing a meniscus in a body with animplant and a suture is provided. The method includes inserting a needlethrough the implant and the meniscus at a first location, delivering afirst anchor of the suture to an opposite side of the meniscus,retracting the needle from the meniscus and the implant, inserting theneedle through the implant and the meniscus at a second location, anddelivering a second anchor of the suture to the opposite side of themeniscus. The second anchor is connected to the first anchor with aflexible portion of the suture. The method also includes pushing aself-locking slide knot located along the flexible portion between thefirst anchor and the second anchor to a surface of the implant. Thedelivering of the second anchor and the pushing the self-locking knotare completed without removing the needle from the body.

In an embodiment, a method for repairing a tear in a meniscus in a bodywith a suture is provided. The method includes inserting a needlethrough the meniscus at a first location, delivering a first anchor ofthe suture to an opposite side of the meniscus, retracting the needlefrom the meniscus, inserting the needle through the meniscus at a secondlocation on an opposite side of the tear as the first location, anddelivering a second anchor of the suture to the opposite side of themeniscus. The second anchor is connected to the first anchor with aflexible portion of the suture. The method further includes pushing aself-locking slide knot located along the flexible portion between thefirst anchor and the second anchor to a surface of the meniscus. Thedelivering of the second anchor and the pushing of the self-locking knotare completed without removing the needle from the body.

In an embodiment, an applicator for delivering a suture to an implantfor repairing a meniscus in a body is provided. The suture includes afirst anchor, a second anchor, and a flexible portion that connects thefirst anchor to the second anchor. The applicator includes a needlehaving a longitudinal bore. The longitudinal bore is configured toreceive the first anchor and the second anchor. The applicator alsoincludes a pusher for pushing the first anchor and the second anchor outof the longitudinal bore of the needle. The pusher is configured toreceive the flexible portion therein and expose a portion of theflexible portion of the suture. The applicator also includes a cuttingsurface configured to cut the suture.

With minor alterations, this anchor delivery system device may be usedin other procedures for soft-tissue repair, and most preferably forarthroscopic procedures. Examples include, but are not limited to use inreparative procedures for soft tissue damage in joints, securing tissuegrafts, and attaching resorbable implants and synthetic scaffolds tohost tissue.

Other aspects, features, and advantages of the present invention willbecome apparent from the following detailed description, theaccompanying drawings, and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Features of the invention are shown in the drawings, in which likereference numerals designate like elements. The drawings form part ofthis original disclosure, in which:

FIG. 1 is a side view of an embodiment of a system for all-inside suturefixation for implant attachment and soft tissue repair of the presentinvention;

FIG. 2 is a top view of an embodiment of a needle of the system of FIG.1;

FIG. 3 is a side view of the needle of FIG. 2;

FIG. 4 is a cross-sectional view taken along line 4-4 in FIG. 2;

FIG. 5 is a side view of another embodiment of the needle for the systemof FIG. 1;

FIG. 6 is a top view of the needle of FIG. 5;

FIG. 7 is a cross-sectional view taken along line 7-7 in FIG. 6;

FIG. 8 is a side view of a pusher of the system of FIG. 1;

FIG. 9 is a top view of an anchor of a suture of the system of FIG. 1;

FIG. 10 is an end view of the anchor of FIG. 9;

FIG. 11 is a side view of the anchor of FIG. 9;

FIG. 12 is a top view of another embodiment of an anchor of the suturefor the system of FIG. 1;

FIG. 13 is an end view of the anchor of FIG. 12;

FIG. 14 is a side view of the anchor of FIG. 12;

FIG. 15 is a view of an anchor threaded onto a flexible portion of thesuture of the system of FIG. 1;

FIG. 16 is a view of the anchor and the flexible portion of FIG. 15 witha loop and a self-locking slide knot formed in the flexible portion;

FIG. 17 is a view of the anchor and the flexible portion of FIG. 16 witha second anchor positioned on the flexible portion;

FIG. 18 is a partial view of the second anchor and the flexible portionof FIG. 17;

FIG. 19 is a partial view of the second anchor and the flexible portionof FIG. 17 with a needle threaded on the flexible portion;

FIG. 20 is a partial view of the needle threaded on the flexible portionand passing through the center of the suture at the second anchor;

FIG. 21 is a partial view of the needle passing through the center ofthe suture at the second anchor a second time;

FIG. 22 is a view of the anchor with a knot securing it to the flexibleportion;

FIG. 23 is a partial view of the flexible portion and the second anchorat one end thereof;

FIG. 24 is a perspective view of a meniscus with an implant positionedon the meniscus;

FIG. 25 is a view of the implant after it has been stapled to themeniscus;

FIG. 26 is a view of the suture of the system of FIG. 1;

FIG. 27 is a top view of the needle with the pusher extended therefrom;

FIG. 28 is a side view of the suture being threaded into the pusher andthe needle;

FIG. 29 is a side view of the suture further being threaded into thepusher and the needle;

FIG. 30 is a top view of the needle with the suture loaded therein;

FIG. 31 is a side view of the needle of FIG. 30;

FIG. 32 is a top view of the needle of the system of FIG. 1 piercing theimplant and meniscus of FIG. 25 at a first location;

FIG. 33 is a top view of the needle of FIG. 32 after the first anchorhas been ejected from the needle with the pusher;

FIG. 34 is a perspective view of the needle of FIG. 32 after it has beenpulled back through the meniscus and implant;

FIG. 35 is a top view of the needle of FIG. 32 piercing the implant andmeniscus of FIG. 25 at a second location;

FIG. 36 is a top view of the needle of FIG. 35 after the second anchorhas been ejected from the needle with the pusher;

FIG. 37 is a top view of the needle of FIG. 35 after is has been pulledback through the meniscus and implant;

FIG. 38 is a top view of the needle of FIG. 37 with the pusher extendedout of the needle;

FIG. 39 is a top view of the needle of FIG. 38 with the pusher pushingthe knot against the implant;

FIG. 40 is a top view of the needle of FIG. 39 after it has been pulledback following knot pushing and suture tensioning;

FIG. 41 is a side view of the needle of FIG. 40 with the suture exposedto the needle cutting surface;

FIG. 42 is a side view of another embodiment of the needle of FIG. 40with the suture exposed to a cutting surface on a cutting sheath; and

FIG. 43 is a top view of the repaired meniscus with the suture tightlyin place.

DETAILED DESCRIPTION OF THE INVENTION

A system 1 for repairing a meniscus according to embodiments of thepresent invention is illustrated in FIG. 1. The system 1 includes anapplicator 10 that is constructed and arranged to deploy a suture 12 tothe meniscus. The suture 12 generally includes a flexible portion 58 anda pair of anchors 60, 70. The suture 12 will be discussed in greaterdetail below.

The application 10 includes a body portion 14 that defines a handle 16that is configured to be grasped by the user. The body portion 14 of theapplicator 10 receives a cannula 18 that extends from the body portion14 in a direction that is away from the handle 16. The body portion 14and cannula 18 may be constructed and arranged like those described andshown in U.S. Pat. No. 5,928,252, entitled Device and Method for Drivinga Needle and Meniscal Repair, which is incorporated herein by referencein its entirety. Because the inner workings of the body portion 14 arenot related to the present invention, they are not described in detailherein.

The applicator 10 also includes a needle 20 that is connected to adistal end of the cannula 18. Of course, the needle 20 may be consideredto be a part of the cannula 18 itself. The needle 20 will be describedin greater detail below. The applicator 10 also includes a pusher 23that includes a hollow rod 24 that extends through the body portion 14,the cannula 18, and is slidingly received by the needle 20. A knob 26 isattached to one end of the rod 24 and a spacer 28 with a tab 29 isdisposed between the knob 26 and a proximal end 15 of the body portion14 so that the movement of the knob 26 relative to the body portion 14and, hence, movement of the rod 24 relative to the needle 20, may belimited to prevent premature ejection of one of the anchors 60 prior tothe placement of the other anchor 70, as described in further detailbelow. A trigger 30 is connected to and extends from the body portion14, as shown in FIG. 1. The trigger 30 is configured to manually controlthe advancement of the rod 24 within the cannula 18. A side lever 32 isconnected to the body portion so as to be pivotable thereon. Operationof the side lever 32 will be discussed in greater detail below.

As shown in FIG. 1, a depth penetration limiter 21 is placed over thedistal end of the cannula 18 so as to partially cover the needle 20. Thelimiter 21 provides the user with a visualization of the depth of theneedle 20 in the tissue to avoid neurovascular injury. An outer sheath22 is placed over the limiter 21 to aid in the insertion of the cannula18 into the incision already created in the patient. The outer sheath 22is preferably designed to partially surround the limiter 21 so that theuser may still see at least a portion of the limiter 21 when the needle20 is being inserted into the incision. The outer sheath 22 is removedby the user once the cannula 18 has been inserted into the incisionsite.

One embodiment of a needle 20 a that may be used as the needle 20 inFIG. 1 is shown in FIGS. 2-4. As shown, the needle 20 a includes asleeve 34 a that is attached to the cannula 18 at a proximal end. Theneedle 20 a also includes a distal end 36 a that is connected to thesleeve 34 a and is constructed and arranged to be inserted into ameniscus or a tissue. The distal end 36 a is substantially straight andincludes a point 38 a for piercing the meniscus or tissue and a slot 40a, which allows for the flexible portion 58 of the suture 12 to extendout of the needle 20 a. As shown in the Figures, the distal end 36 a ofthe needle 20 a also includes a cutting surface 37 a that is constructedand arranged to cut excess suture 12, which will be described in greaterdetail below.

As shown in FIGS. 2-4, a cutting sheath 35 a that at least partiallysurrounds the distal end 36 a may also be provided. In the illustratedembodiment, the cutting sheath 35 a completely surrounds thecircumference of the distal end 36 a. In other embodiments, the cuttingsheath 35 a may only partially surround the distal end 36 a. The cuttingsheath 35 a is configured to be slidable relative to the distal end 36 aso that it may be moved longitudinally along the distal end 36 a towardthe point 38 a, and then moved back again toward the sleeve 34 a. Thecutting sheath 35 a may include a tab that extends outward from theneedle 20 a so that the user my manipulate the cutting sheath 35 a viathe tab. As shown, the cutting sheath 35 a includes at least one cuttingsurface 33 a that is constructed and arranged to cut excess suture 12,which will be described in greater detail below.

As shown in FIG. 4, the distal end 36 a is configured to hold the pairof anchors 60, 70 of the suture 12. The needle 20 a may include a dimple39 a located near the point 38 a to assist in seating the anchors 60, 70prior to deployment of the anchors 60, 70 from the needle 20 a, as willbe described in greater detail below. The needle 20 a is preferablymanufactured from stainless steel, and is sized to withstand insertionthrough the implant and the meniscus substantially without bending orbuckling.

Another embodiment of a needle 20 b that may be used as the needle 20 inthe applicator 10 is shown in FIGS. 5-7. As shown, the needle 20 bincludes a sleeve 34 b that is attached to the cannula 18 at a proximalend. The needle 20 b also includes a distal end 36 b that is connectedto the sleeve 34 b and is constructed and arranged to be inserted into ameniscus or a tissue. The distal end 36 b is curved such that it extendsat an angle α relative to the sleeve 34 b. The angle α may be about15-45°, and is preferably about 30°. The distal end 36 b also includes apoint 38 b for piercing the meniscus or tissue and a slot 40 b, whichallows for portions of the suture 12 to extend out of the needle 20 b.The distal end 36 b of the needle 20 b also includes at least onecutting surface 37 b that is constructed and arranged to cut excesssuture 12.

As shown in FIGS. 5-7, a cutting sheath 35 b that at least partiallysurrounds the distal end 36 b may also be provided. In the illustratedembodiment, the cutting sheath 35 b completely surrounds thecircumference of the distal end 36 b. In other embodiments, the cuttingsheath 35 b may only partially surrounds the distal end 36 b. Thecutting sheath 35 b is configured to be slidable relative to the distalend 36 b so that it may be moved longitudinally along the distal end 36b toward the point 38 b, and back again to the sleeve 34 b. The cuttingsheath 35 b may include a tab that extends outward from the needle 20 bso that the user my manipulate the cutting sheath 35 b via the tab. Asshown, the cutting sheath 35 b includes a cutting surface 33 b that isconstructed and arranged to cut excess suture 12.

As shown in FIG. 7, the distal end 36 b is also configured to hold thepair of anchors 60, 70. The needle 20 b may also include a dimple 39 blocated near the point 38 b to assist in seating the anchors 60, 70prior to deployment. Like the needle 20 a of FIGS. 2-4, the needle 20 bis preferably manufactured from stainless steel, and is sized towithstand insertion through the implant and the meniscus substantiallywithout bending or buckling.

An embodiment of the pusher 23 is shown in greater detail in FIG. 8. Therod 24 is hollow and is configured to receive the flexible portion 58 ofthe suture 12 that extends away from the needle 20. The knob 26 includesa hole for receiving the rod 24, so that the flexible portion 58 of thesuture 12 may extend through the knob 26 as well. A distal portion ofthe rod 24 includes a pair of slots 42 that are configured to allow theflexible portion 58 of the suture 12 to be threaded out of the rod 24via one slot 42 (the distal slot) and back into the rod 24 via the otherslot 42 (the proximal slot), as represented by an exposed portion 44 ofthe flexible portion 58 of the suture 12. This threading of the suture12 properly aligns the exposed portion 44 relative to the rod 24 tofacilitate the cutting of the suture 12, which will be described infurther detail below. As shown in FIG. 7, the rod 24 may be flexible sothat it may be used with the embodiment of the needle 20 b describedabove.

FIGS. 9-11 illustrated an embodiment of an anchor 46 that may be used asthe anchors 60, 70 of the suture 12. As shown, the anchor 46 includes atab 48 that extends upward from a body 50. The body 50 has opposing ends51 that are substantially perpendicular to a longitudinal axis LA of theanchor 46. A hole 52 that is centered on the longitudinal axis LAextends through the body 50 and the tab 48 where the body 50 and tab 48are connected. Otherwise, the body 50 includes a hollowed outhalf-cylinder 53 at portions where the tab 48 is not connected. Theanchor 46 is preferably made out of a bioabsorbable polymer, such aspoly(L-lactide).

Another embodiment of an anchor 54 for use in the suture 12 of thesystem 1 is shown in FIGS. 12-14. As shown, the anchor 54 is a solid rodwith a pair of holes 56 that extend substantially perpendicularlythrough the longitudinal axis of the rod. The holes 56 are sized toreceive a flexible portion of the suture 12. A recessed channel 57 islocated between the holes 56 to seat the flexible portion 58 of thesuture 12. Like the anchor 46, the anchor 54 is preferably made out of abioabsorbable polymer, such as poly(L-lactide).

In another embodiment of an anchor that may be used as one or both ofthe anchors 60, 70 of the suture 12, the anchor may include at least onebarb that is formed from or connected to a main body portion of theanchor. The barb may be constructed and arranged to be biased to anorientation in which a free end of the barb extends away from the body,yet is oriented such that the free end is near the body when suitablepressure is applied to the barb. The use of such an anchor with thesystem 1 will be described in greater detail below.

Unless otherwise indicated herein, further discussions of the anchors60, 70 will be for the anchor 46 illustrated in FIGS. 9-11, although itis understood that the anchor 54 of FIGS. 12-14 may be used with slightmodifications to the language used to describe the assembly of thesuture 12. Such modifications would be readily appreciated by one ofskill in the art and are therefore not described herein.

FIGS. 15-23 show the various stages of an embodiment of assembling thesuture 12 of the system 1 of FIG. 1. FIG. 15 shows the flexible portion58 of the suture 12 with one anchor 60 threaded thereon. FIG. 16 shows aloop 62 and a knot 64 that closes the loop 62, with the anchor 60 beinglocated within the loop 62. The knot 64 is preferably a self-lockingslide knot. Methods for tying a self-locking slide knot are describedin, for example, “A New Clinch Knot,” Weston, P. V., Obstetrics &Gynecology, Vol. 78, pp. 144-47 (1991); “Physical Properties of SelfLocking and Conventional Surgical Knots,” Israelsson, L. A., et al.,European Journal of Surgery, Vol. 160, No. 6-7, pp. 323-27 (1994);“Nicky's Knot—A New Slip Knot for Arthroscopic Surgery,” De Beer, J. F.,et al., Arthroscopy: The Journal of Arthroscopic and Relate Surgery,Vol. 14, No 1, pp. 109-110 (1998); “The Giant Knot: A New One-WaySelf-Locking Secured Arthroscopic Slip Knot,” Fleega, B. A., et al.,Arthroscopy: The Journal of Arthroscopic and Relate Surgery, Vol. 15, No4, pp. 451-52 (1999); “Arthroscopic Knot Tying Techniques,” Nottage, W.M., et al., Arthroscopy: The Journal of Arthroscopic and Relate Surgery,Vol. 15, No 5, pp. 515-521 (1999); “The SMC Knot—A New Slip Knot WithLocking Mechanism,” Kim, S., et al., Arthroscopy: The Journal ofArthroscopic and Relate Surgery, Vol. 16, No 5, pp. 563-65 (2000);“Technical Note: A ‘New’ Arthroscopic Sliding Knot,” Field, M. H., etal., Orthopedic Clinics of North America, Vol. 32, No. 3, pp. 525-26(2001); “Arthroscopic Knot Tying,” Kim, S., et al., Techniques inShoulder & Elbow Surgery, Vol. 4, No. 2, pp. 35-43 (2003); “The PC Knot:A Secure and Satisfying Arthroscopic Slip Knot,” Pallia, C. S.,Arthroscopy: The Journal of Arthroscopic and Relate Surgery, Vol. 19, No5, pp. 558-560 (2003); and “The Tuckahoe Knot: A Secure Locking SlipKnot,” Wiley, W. B., et al., Arthroscopy: The Journal of Arthroscopicand Relate Surgery, Vol. 20, No 5, pp. 556-59 (2004), all of which areincorporated herein by reference in their entireties.

Once the self-locking slide knot 64 has been tied, another anchor 70 isslid onto the flexible portion 58 until it is located approximately 7 mmfrom the knot 64, as shown in FIG. 17 (note that the Figures are notnecessarily drawn to scale). This distance is only meant to be anexample and is not intended to be limiting in any way. The flexibleportion 58 of the suture 12 is tied off with one hitch knot 74 on theanchor 70, as shown in FIG. 18.

Next, as shown in FIG. 19, a needle 72 is threaded with the remainder ofthe flexible portion 58. The end of the flexible portion 58 with theneedle 72 is passed through the center of the suture of the hitch knottwice to hold the hitch knot 74 in place, as shown in FIGS. 20 and 21.As shown in FIG. 22, the excess flexible portion 58 is cut, leavingapproximately 2 mm as a tail. Finally, as shown in FIG. 23, the tip ofthe flexible portion 58 may be melted to prevent fraying of the suture12. An assembled suture 12 before it is loaded into the applicator 10 isshown in FIG. 26.

FIG. 24 shows a damaged meniscus 80 having a rim 81, and an implant 82positioned adjacent the damaged part of the meniscus 80. The implant 82may be any type of implant 82 suitable for such meniscus repair.Preferably, the implant 82 includes collagen. In an embodiment, theimplant 82 includes the CMI, a collagen-based meniscus implant. Theimplant 82 illustrated in the Figures has already been cut to theappropriate size. Both ends of the implant 82 may be temporarily stapledor sutured using conventional means to hold the implant 82 in placewhile it is being secured to the meniscus 80. FIG. 25 shows a pair ofstaples 84, or sutures, holding the implant 82 in place.

To load the suture 12 into the applicator 10, the cannula 18, with theneedle 20 a attached, is inserted into the body portion 14 of theapplicator 10. In this embodiment, the needle 20 a of FIGS. 2-4 isshown. However, it is understood that the needle 20 b may also be usedin the same way. The illustrated and described embodiments are notintended to be limiting in any way. While holding down the side lever 32with a finger or a thumb, the rod 24 of the pusher 23 is inserted by theuser into the proximal end 15 of the body portion 14, until the end ofthe rod 24 extends past the point 38 a of the needle 20 a with the slots42 facing upward, as shown in FIG. 27.

Next, as shown in FIG. 28, an end 59 of the suture 12 that is oppositethe anchor 70 is threaded though the rod 24 of the pusher 23 at thedistal end 36 a of the needle 20 a. The end 59 of the suture 12 is lacedthrough the distal end of the rod 24, pulled out of the rod 24 at thedistal slot 42, threaded back into the rod 24 at the proximal slot 42,thereby leaving the exposed portion 44 outside of the rod 24. The end 59of the suture 12 may extend several inches outside the pusher 23 beyondthe proximal end 15 of the body portion 14 of the applicator 10 so thatthe user may grasp the suture 12 during the implant attachmentprocedure, which will be described below. Once the suture 12 has beenloaded into the applicator 10, the user then presses the side lever 32and retracts the pusher 23 back into the needle 20 a, as shown in FIG.29, to locate the slots 42 and the exposed portion 44 of the suture 12before the proximal end of the needle slot 40 a, as shown in FIG. 30.The anchor 60 is inserted into the distal end 36 a of the needle 20 a,and is followed by the anchor 70, as shown in FIGS. 30 and 31. The end59 of the flexible portion 58 that extends out of the pusher 23 at theproximal end 15 of the body portion 14 of the applicator 10 may bepulled so that the knot 64 is generally located on a side of the anchor60 that is opposite the other anchor 70, as shown in FIG. 31 After theanchors 60, 70 are loaded into the cannula 18, a portion of the flexibleportion 58 may extend outside of the cannula 18 via the slot 40 a of theneedle 20 a, as shown in FIGS. 30 and 31. In this arrangement, thepulling of the trigger 30 causes the anchor 70, the anchor 60, and theknot 64 to be deployed in that order.

Once the system 1 is assembled, the user places the spacer 28 betweenthe knob 26 and the proximal end 15 of the body portion 14 so that theadvancement of the anchor 60 will be limited until the placement of theanchor 70 is complete. The user then inserts the depth penetrationlimiter 21 and the outer sheath 22 over the distal end of the cannula 18so as to cover the needle 20 during insertion of the needle 20 into theincision site. Once the needle 20 has been inserted into the incisionsite, the outer sheath 22 may be removed from the cannula 18. Of course,the use of the spacer 28, the outer sheath 22, and the depth penetrationlimiter 21 should be considered optional. The illustrated embodiment isnot intended to be limiting in any way.

The user may then advance the anchors 60, 70 until the anchor 70 islocated near the point 38 a of the needle 20 a, without extending out ofthe needle 20 a. The dimple 39 a may be used to assist with theplacement of the anchor 70. In embodiments where the dimple 39 a isused, the user should feel a slight resistance to the advancement of theanchor 70, which signals the user to stop advancing the pusher 23. Ofcourse, the use of the dimple 39 a should be considered to be optional.The illustrated embodiment is not intended to be limiting in any way.

While griping the handle 16 and the trigger 30 on the applicator 10, theuser inserts the needle 20 a into a patient at an incision site so thatthe needle 20 a may then be inserted through the implant 82 and throughthe meniscus 80 at a first location 86, preferably near the center ofthe implant 82, to a side opposite the insertion site, as shown in FIG.32. The user should be sure that the hitch knot 74 on the anchor 70 haspassed through the meniscus 80, as shown in FIG. 32. In an embodiment,the user then advances the pusher 23 via the trigger 30 until the anchor70 is pushed outside the needle 20 a, as shown in FIG. 33. The usershould be careful to not advance the pusher 23 further to avoid thepremature deployment of the anchor 60. The use of the spacer 28 assistsin preventing the premature deployment of the anchor 60. In addition to,or in lieu of the spacer 23, the dimple 39 a that is located near thepoint 38 a of the needle 20 a may also be used to provide the user withtactile feedback that the anchor 60 has been advanced to its properpre-deployment position.

As shown in FIG. 34, the user then retracts the needle 20 a slowly fromthe meniscus 80 and the implant 82, leaving the anchor 70 behind on theopposite side of the meniscus 80. The anchor 60 will remain inside theneedle 20 a. If the user hasn't already done so, the user next advancesthe anchor 60 until the anchor 60 is located near the point 38 a of theneedle 20 a. Again for embodiments that include the dimple 39 a, thedimple 39 a may be used to guide the user to correctly position theanchor 60.

While gripping the handle 16 and the trigger 30 on the applicator 10,the user inserts the needle 20 a though the implant 82 and through themeniscus 80 at a second location 88, which is preferably near the firstlocation 86, until the center of the anchor 60 is outside the oppositeside of the meniscus 80, as shown in FIG. 35. If the user hasn't alreadydone so, the user next removes the spacer 28 from the rod 24 by graspingthe tab 29 and pulling the spacer 28 away from the rod 24. The user thenadvances the pusher 23 until the anchor 60 is pushed outside the needle20 a, as shown in FIG. 36. The user then retracts the needle 20 a,thereby leaving the anchor 60 on the opposite side of the meniscus 80,as shown in FIG. 37.

Having deployed both anchors 60, 70, the user may then advance thepusher 23 via the trigger 30 so that the rod 24 extends approximately 1cm beyond the point 38 a of the needle 20 a, as shown in FIG. 38. Whilegripping the handle 16 and the trigger 30 of the applicator 10, the userthen holds the tip of the rod 24 against the knot 64 and pushes the knot64 to the surface of the implant 82, being careful not to push the knot64 through the implant 82. The user continues to grip the handle 16 andthe trigger 30 while gently pulling on the end 59 of the flexibleportion 58 of the suture 12 at the proximal end 15 of the body portion14 of the applicator 10 until slack in the suture 12 is taken up, andthe anchors 60, 70 sit flat against the meniscus 80, as shown in FIGS.39 and 40.

With the knot 64 now secured, the user may extend the rod 24 of thepusher 23 out of the needle 20 a approximately 1 cm. The user may thenrotate the pusher 23 up to approximately 180°, or until the slots 42 andthe exposed portion 44 of the suture 12 are positioned to come intocontact with the cutting surface 37 a when the pusher 23 is pulled backtoward the proximal end 15 of the body portion 14 of the applicator 10,as shown in FIG. 41. Holding the end 59 of the flexible portion 58 thatextends out of the proximal end 15, the user may shear the exposedportion 44 of the suture 12 against the cutting surface 37 a by slidingthe pusher 23 longitudinally against the cutting surface 37 a, as shownin FIG. 41, thereby leaving a short tail 67 near the knot 64, as shownin FIG. 43. The pusher 23 may have to be moved back and forth againstthe cutting surface 37 a before the suture 12 is fully cut.

In another embodiment, after the knot 64 is secured, while holding theend 59 of the flexible portion 58 that extends out of the proximal end15, the user may shear the exposed portion 44 of the suture 12 againstthe cutting surface 33 a by sliding the cutting sheath 35 a along thedistal end 36 a and toward the point 38 a of the needle 20 a, as shownin FIG. 42, thereby leaving a short tail 67 near the knot 64, as shownin FIG. 43. The cutting sheath 35 a may have to be moved back and forthalong the distal end of the needle 20 a before the suture 12 is fullycut.

The aforementioned system 1 and method provide an all-inside suturefixation to the implant and meniscus, because the needle 20 a of theapplicator 10 has not been removed from the patient's body between thedeployment of the anchor 70, the pushing of the knot 64, and the cuttingof the excess flexible portion 58 of the suture 12. This may bebeneficial to the patient because it may reduce the time the applicator10 is in the patient's body, and allows for a single, small entry pointof the needle 20 a, at the incision, into the patient's body.

The user may then repeat the steps shown in FIGS. 32-43 for anyremaining sutures 12 that are needed to complete the fixation of theimplant 82 to the meniscus 80. Generally, it may take three or moresutures 12 to secure the implant 82.

Of course, in alternative embodiments, the user may remove the bodyportion 14 of the applicator 10 and pusher 23 from the cannula 18, andtrim the excess flexible portion 58 of the suture 12 with scissors, orsome other cutting device. The illustrated embodiments are not intendedto be limiting in any way.

Also, in alternative embodiments, one or both of the anchors 60, 70 maybe the anchor described above that includes one or more barbs. Thisallows the user to advance the pusher 23 via the trigger 30 only until adistal end of the anchor is located adjacent the point of the needle 20in an orientation in which the barb is no longer engaged by the wall ofthe needle 20. When the anchor is in this position, the wall of theneedle 20 is no longer exerting pressure on the barb, thereby allowingthe barb to be biased outward and away from the body of the anchor. Thebarb may then be used to engage the anchor with the meniscus 80 so thatwhen the user pulls the needle 20 back through the meniscus 80 and theimplant 82, the entirety of the anchor will pull out of the needle 20without further advancement of the pusher 23.

It is also contemplated that the needle 20 may be designed such that thetab 48 on the anchor 46 may be used to engage the anchor 46 with themeniscus 80 before the anchor 46 exits the needle 20. This allows theentirety of the anchor 46 to be pulled out of the needle 20 when theneedle 20 is pulled back through the meniscus 80, rather than pushingthe entirety of the anchor 46 out of the needle 20 with the pusher 23,as described in the embodiments above.

Although the above-described procedure was in the context of attachingan implant to a meniscus with needle penetration of the implant and themeniscus in a substantially horizontal stitch, a substantially similarprocedure may be used for the placement of other types of stitches, suchas vertical and oblique, as would be appreciated by one of skill in theart. The illustrated and described embodiments should not be consideredto be limiting in any way.

In addition, although the above-described procedure was in the contextof attaching an implant to a meniscus, a substantially similar proceduremay be used to repair soft tissue, as would be appreciated by one ofskill in the art. The illustrated and described embodiments should notbe considered to be limiting in any way. For example, to repair a tearin the meniscus 80 with the suture 12, the needle 20 may be insertedthrough the meniscus 80 a first location near the tear. The first anchor70 of the suture 12 may then be delivered to an opposite side of themeniscus 80, and the needle 20 retracted from the meniscus 80, withoutpulling out of the body. The needle may then be inserted through themeniscus 80 at a second location on an opposite side of the tear as thefirst location. The second anchor 60 of the suture 12 may then bedelivered to the opposite side of the meniscus 80. Once the secondanchor 60 is in the proper position, the user may then push the knot 64to a surface of the meniscus 80 to tighten the suture. The excess of theflexible portion 58 of the suture 12 may then be cut with any of thecutting methods described above.

The foregoing disclosure of embodiments of the present invention hasbeen presented for purposes of illustration and description. It is notintended to be exhaustive or to limit the invention to the precise formsdisclosed. Many variations and modifications of the embodimentsdescribed herein will be apparent to one of ordinary skill in the art inlight of the above disclosure. The scope of the invention is to bedefined only by the claims appended hereto, and by their equivalents.

Further, in describing representative embodiments of the presentinvention, the specification may have presented the method and/orprocess of the present invention as a particular sequence of steps.However, to the extent that the method or process does not rely on theparticular order of steps set forth herein, the method or process shouldnot be limited to the particular sequence of steps described. Forexample, any number of sutures may be prepared ahead of time. Inaddition, the advancement of the anchors within the cannula may occurbefore or after needle insertion. In addition, the delivery of thesecond anchor may not require that the needle be fully withdrawn; forexample when two anchors are to be delivered through a single insertionsite. As one of ordinary skill in the art would appreciate, othersequences of steps may be possible. Therefore, the particular order ofthe steps set forth herein should not be construed as limitations on theclaims. In addition, the claims directed to the method and/or process ofthe present invention should not be limited to the performance of theirsteps in the order written, and one skilled in the art can readilyappreciate that the sequences may be varied and still remain within thespirit and scope of the present invention.

1. A system for repairing a meniscus comprising: a suture including afirst anchor, a second anchor, and a flexible portion connecting thefirst anchor and the second anchor, the flexible portion including aself-locking slide knot between the first anchor and the second anchor;a needle having a longitudinal extending bore and an open end, the borebeing configured to receive the first anchor and the second anchor; anda pusher configured to be movable within the bore of the needle, thepusher being configured to (1) discharge the first anchor and the secondanchor, and (2) push the self-locking slide knot after the discharge ofthe second anchor.
 2. The system according to claim 1, furthercomprising a cutting surface for cutting the flexible portion of thesuture.
 3. The system according to claim 2, wherein the needle comprisesthe cutting surface at the open end, and wherein the pusher isconfigured to align the flexible portion of the suture with the cuttingsurface and move relative to the cutting surface so as to cut theflexible portion of the suture.
 4. The system according to claim 2,wherein the cutting surface is disposed on a cutting sheath that atleast partially surrounds the needle, and wherein the cutting sheath isconfigured to move relative to the needle so as to cut the flexibleportion of the suture.
 5. The system according to claim 2, wherein thepusher comprises a hollow rod with a pair of slots, the slots beingconfigured to expose a portion of the flexible portion of the suture sothat the exposed portion is cut against the cutting surface.
 6. Thesystem according to claim 1, wherein the needle includes a dimpleadjacent to the open end, the dimple being configured to locate thefirst anchor and the second anchor prior to discharge from the needle.7. The system according to claim 1, further comprising a spacer forpositioning the pusher relative to the needle, the spacer beingconfigured to limit movement of the pusher when the first anchor isbeing discharged. 8-28. (canceled)
 29. An applicator for delivering asuture for repairing a meniscus in a body, the suture comprising a firstanchor, a second anchor, and a flexible portion that connects the firstanchor to the second anchor, the applicator comprising: a needle havinga longitudinal bore, the longitudinal bore being configured to receivethe first anchor and the second anchor; a pusher for pushing the firstanchor and the second anchor out of the longitudinal bore of the needle,the pusher being configured to receive the flexible portion therein andexpose a portion of the flexible portion of the suture; and a cuttingsurface configured to cut the suture.
 30. An applicator according toclaim 29, wherein the applicator is configured to shear the exposedportion of the suture against the cutting surface.
 31. An applicatoraccording to claim 30, wherein the cutting surface is located on theneedle and the pusher is configured to shear the exposed portion of thesuture against the cutting surface.
 32. An applicator according to claim30, further comprising a cutting sheath at least partially surroundingthe needle, wherein the cutting surface is located on the cutting sheathand the cutting sheath is configured to shear the exposed portion of thesuture against the cutting surface.